On July 15, 2020 Idera Pharmaceuticals, Inc. (Nasdaq: IDRA) reported entering into an agreement with a fund affiliated with institutional investors providing for a private placement exempt from the registration requirements of the Securities Act of 1933, as amended, pursuant to which Idera has sold shares of common stock (or common stock equivalents), together with accompanying warrants to purchase an additional shares of common stock, for aggregate gross proceeds of $5.1 million (Tranche 1) (Press release, Idera Pharmaceuticals, JUL 15, 2020, View Source [SID1234561880]). The combined purchase price per share of common stock (or common stock equivalent) and accompanying full warrant was $1.845. The common stock warrants have an exercise price of $2.58 per share and a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of 19.99% of the total number of shares of common stock then issued and outstanding (Beneficial Ownership Limitation).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Pursuant to the agreement, the investors may, at their option, make a further investment of an additional $5.1 million to purchase shares of common stock equivalents, together with accompanying common stock warrants to purchase additional shares of common stock with 35% warrant coverage (Tranche 2). The combined purchase price per share of common stock (or common stock equivalent) and accompanying 0.35 warrant will be $6.50 per share. The common stock warrants, if issued, will have an exercise price of $9.75 per share, a term of three years and are exercisable at any time or times, provided that the investors will be prohibited from exercising a common warrant for shares of common stock to the extent that the investors would beneficially own in excess of the Beneficial Ownership Limitation.

The investors’ option to invest in Tranche 2 must occur no later than the tenth business day following the announcement of overall response rate data from the Company’s ILLUMINATE-301 trial of its lead product, tilsotolimod, in combination with ipilimumab for the treatment of anti-PD-1 refractory advanced melanoma. To the extent Tranche 2 is closed and inclusive of proceeds from the exercise of warrants issuable in this private placement, the Company may receive up to $20.0 million in gross proceeds.

The Company plans to use the initial proceeds and, if exercised, subsequent proceeds from the financing for the ongoing clinical development of tilsotolimod, its potential NDA filing and commercial launch, and for general corporate purposes.

The shares of common stock (or common stock equivalents) and warrants sold in the private placement have not been registered under the Securities Act of 1933, as amended, or under any state securities laws and, unless so registered, may not be offered or sold in the United States except pursuant to an exemption from, or in a transaction not subject to, the registration requirements of the Securities Act and applicable state securities laws.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Tilsotolimod (IMO-2125)
Tilsotolimod is an investigational, synthetic Toll-like receptor 9 agonist. Intratumoral injection of tilsotolimod has been shown to promote both innate (Type-I IFN, antigen presentation) and adaptive (T cells) immune activation. Tumors with an active immune response appear to respond better to CPIs than those that exclude or inhibit anti-tumor immune cells. Tilsotolimod in combination with CPIs may cause regression of locally injected and distant tumor lesions and increase the number of patients who benefit from immunotherapy.

Tilsotolimod has received both Fast Track designation and Orphan Drug designation from the FDA and is being evaluated in multiple tumor types and in combination with multiple checkpoint inhibitors. For more information on tilsotolimod trials, please visit www.clinicaltrials.gov.

On July 15, 2020 Novocure (NASDAQ: NVCR) reported it has entered into a clinical trial collaboration agreement with MSD (a tradename of Merck & Co., Inc.), through a subsidiary, to develop Tumor Treating Fields together with MSD’s anti-PD-1 therapy KEYTRUDA (pembrolizumab) for treatment of non-small cell lung cancer (NSCLC) (Press release, NovoCure, JUL 15, 2020, View Source [SID1234561879]). Novocure’s Tumor Treating Fields use electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

The two companies plan to conduct a phase 2 pilot study of Tumor Treating Fields concomitant with KEYTRUDA for first-line treatment of intrathoracic advanced or metastatic, PD-L1 positive NSCLC. The study is designed to enroll approximately 66 patients in the United States and is expected to begin in the second half of 2020. Objective response rate (ORR) is the primary endpoint of the study. Secondary endpoints include overall survival, progression free survival (PFS), PFS at six months, one-year survival rate, duration of response, disease control rate at 18 weeks and safety.

"We are very pleased to collaborate with MSD, a global leader in oncology, in this important combination study as we strive to extend survival in some of the most aggressive forms of cancer through the development and commercialization of Tumor Treating Fields," said William Doyle, Novocure’s Executive Chairman. "Multiple preclinical studies suggest that the use of Tumor Treating Fields together with anti-PD-1 therapy can potentially augment the immune response resulting in improved tumor control. We look forward to generating clinical data demonstrating the effect of Tumor Treating Fields concurrent with KEYTRUDA in first-line NSCLC."

About Lung Cancer

Lung cancer, which forms in the tissues of the lungs, usually within cells lining the air passages, is the leading cause of cancer death worldwide. Each year, more people die from lung cancer than from colon and breast cancers combined. The two main types of lung cancer are non-small cell and small cell. Non-small cell lung cancer (NSCLC) is the most common type of lung cancer, accounting for about 85 percent of all cases. The five-year survival rate for patients diagnosed in the U.S. with NSCLC is approximately 24 percent.

About Tumor Treating Fields

Tumor Treating Fields is a cancer therapy that uses electric fields tuned to specific frequencies to disrupt cell division, inhibiting tumor growth and causing cancer cells to die. Tumor Treating Fields does not stimulate or heat tissue and targets dividing cancer cells of a specific size. Tumor Treating Fields causes minimal damage to healthy cells. Mild to moderate skin irritation is the most common side effect reported. Tumor Treating Fields is approved in certain countries for the treatment of adults with glioblastoma and in the U.S. for mesothelioma, two of the most difficult cancer types to treat. The therapy shows promise in multiple solid tumor types – including some of the most aggressive forms of cancer.

Use of Tumor Treating Fields for the treatment of NSCLC is investigational only.

KEYTRUDA is a registered trademark of Merck Sharp & Dohme Corp., a subsidiary of Merck & Co., Inc., Kenilworth, NJ, USA.

On July 15, 2020 BioAtla, Inc., a global clinical-stage biotechnology company focused on the development of Conditionally Active Biologic (CAB) antibody therapeutics, reported closing of a Series D financing round raising $72.5 million (Press release, BioAtla, JUL 15, 2020, View Source [SID1234561878]). The financing was led by Soleus Capital and joined by several new investors including HBM Healthcare Investments as co-lead, Cormorant Asset Management, Farallon Capital, Pappas Capital, funds managed by Janus Henderson, Boxer Capital, and one other institutional investor. Current investor Pfizer Ventures, the venture capital arm of Pfizer Inc. (NYSE: PFE), also participated in the financing.

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"The funding provided by this group of highly respected investors strongly supports the execution of BioAtla’s current and future product and strategic plans. The proceeds of this financing greatly enhance our ability to design, implement, and execute clinical programs evolving from our CAB platform that uniquely yields tumor-targeting antibodies with the potential for an enhanced benefit risk profile" said Jay M. Short, Ph.D., chairman and chief executive officer of BioAtla. "We look forward to driving Phase 2 trials addressing high unmet medical needs in oncology for our innovative CAB-AXL-ADC (BA3011) and CAB-ROR2-ADC (BA3021) product programs, as well as advancing clinical studies for CAB-CTLA-4 (BA3071)," stated Scott Smith, president of BioAtla. "In addition, we are pursuing development of several T cell-recruiting CAB-bispecific candidates."

About Conditionally Active Biologics (CABs)

Conditionally Active Biologics are proteins generated using BioAtla’s proprietary protein discovery, evolution and expression technologies. These proteins can be monoclonal antibodies, enzymes and other proteins designed with functions dependent on changes in micro physiological conditions (e.g., pH level, oxidation, temperature, pressure, presence of certain ions, hydrophobicity and combinations thereof) both outside and inside cells.

Studies have shown that cancerous tumors create highly specific conditions at their site that are not present in normal tissue. These cancerous microenvironments are primarily a result of the well understood unique glycolytic metabolism associated with cancer cells, referred to as the Warburg Effect in aerobic cancer cells. CAB proteins are designed to deliver their therapeutic payload and/or recruit the immune response in specific and selected locations and conditions within the body and to be active only in the presence of a particular cellular microenvironment. In addition, the activation is designed to be reversible to repeatedly switch ‘on and off’ should the CAB move from a diseased to a normal cellular microenvironment and vice versa. CABs can be developed in a variety of formats, including antibodies, antibody drug conjugates (ADCs), bispecifics, chimeric antigen receptor T-cells (CAR-Ts) and combination therapies.

On July 15, 2020 IntelGenx Technologies Corp. (TSX-V: IGX) (OTCQB: IGXT) (the "Company" or "IntelGenx") reported , that the Company’s Board of Directors approved an amendment to the Amended 2016 Stock Option Plan (the "Plan") to increase the number of shares available for issuances under the Plan by 1,678,218 from 9,347,747 to 11,025,965, or 10% of the Company’s currently issued and outstanding shares (Press release, IntelGenx, JUL 15, 2020, View Source [SID1234561877]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

Furthermore, the Board approved an amendment to the provision concerning the automatic extension of the expiry time of stock options during blackout periods as per the TSX-V Exchange Policy. The Board resolved to remove the condition that the automatic extension during blackout periods needs to be reflected in individual stock option agreements.

The amendments are subject to TSX-Venture Exchange acceptance.

The Second Amended 2016 Stock Option Plan will be available on EDGAR and SEDAR.

On July 15, 2020 I-Mab (the "Company") (Nasdaq: IMAB), a clinical stage biopharmaceutical company committed to the discovery, development and commercialization of novel biologics, reported that its Board of Directors has authorized a stock repurchase program under which the Company may repurchase up to US$20 million of its ordinary shares in the form of American depositary shares (Press release, I-Mab Biopharma, JUL 15, 2020, View Source [SID1234561876]).

Schedule your 30 min Free 1stOncology Demo!
Discover why more than 1,500 members use 1stOncology™ to excel in:

Early/Late Stage Pipeline Development - Target Scouting - Clinical Biomarkers - Indication Selection & Expansion - BD&L Contacts - Conference Reports - Combinatorial Drug Settings - Companion Diagnostics - Drug Repositioning - First-in-class Analysis - Competitive Analysis - Deals & Licensing

                  Schedule Your 30 min Free Demo!

"I am pleased to announce this stock repurchase program," said Dr. Jingwu Zang, M.D., Ph.D., Founder, Honorary Chairman and Director of the Company. "This program underscores our full confidence in the potential of I-Mab’s highly differentiated, globally competitive pipeline. We believe repurchase of I-Mab’s common stock is consistent with our focus on enhancing and delivering long-term shareholder value."

Repurchases, if any, under the program will be made at the discretion of management, and will depend upon market pricing and conditions, business, legal, accounting and other considerations. Any such share purchases will be made by the Company from time to time in open market transactions, or otherwise in compliance with Rule 10b-18 under the Securities Exchange Act of 1934, or pursuant to a trading plan adopted in accordance with Rule 10b5-1 of the Securities Exchange Act of 1934.

The repurchase program is effective upon and from the date on which a formal stock repurchase plan engagement agreement is signed with a qualified broker-dealer(s), and terminates over a twelve-month period depending upon market and economic conditions, and other factors including price, legal and regulatory requirements and capital availability. The program does not obligate I-Mab to acquire any particular number of American depositary shares, and the program may be modified or suspended at any time at the management’s discretion.